Professor of Urology Johns Hopkins University School of Medicine
Introduction: Magnetic resonance imaging-guided transurethral ultrasound ablation (TULSA) of the prostate is an in-bore procedure that thermally coagulates tissue under real-time closed-loop MRI thermometry control, allowing precise adjustment of treatment parameters to match tissue effects. We report 4-year outcomes from the TACT pivotal trial of TULSA in men with low- to intermediate-risk prostate cancer (PCa) (NCT02766543). Methods: Across 13 sites in 5 countries, 115 men with organ-confined PCa underwent a single whole-gland TULSA treatment sparing the prostatic urethra and urinary sphincter. Eligibility criteria included stage = T2b, PSA = 15 ng/mL, and Grade Group (GG)1-2. One-year endpoints included adverse events, quality-of-life (QOL), PSA reduction, histologic control on 10-core biopsy, and prostate volume reduction on mpMRI. Patients are being followed to five years for adverse events, QOL, PSA, and the rate of salvage treatment. Results: Median (IQR) age and PSA at baseline were 65 (59-69) and 6.3 (4.6-7.9) ng/mL, with Grade Group (GG) =2 disease in 72/115 men (63%; 60% GG2; 3% GG3 included with protocol deviation). Median (IQR) ablation time was 51 (39-66) min. Median prostate volume decreased from 37.3 to 2.8 cc (92%). At the 1-year biopsy, 94/111 (85%) were free of =GG2 disease, 88/111 (79%) were free of GG2 or high-volume GG1 disease, 16/111 (14%) had low-volume GG1. By 4 years 18 men (16%) received salvage treatment (8 radical prostatectomy, 8 radiation therapy, 1 androgen deprivation therapy, 1 surgery plus radiation) without unexpected complications. At 4 years, median (IQR) PSA was 0.9 (0.4-1.6) ng/mL, a reduction of 86% (75%-95%) from baseline and of 96% to the nadir (n=76). Median IPSS decreased from 7 at baseline to 5 at 4 years (n=73). Erections sufficient for penetration (IIEFQ2=2) were recovered by 69/92 (75%) at 1 year, and 46/57 (81%) at 4 years. Pad-free urinary continence was preserved at 1 and 4 years in 102/111 (92%) and 68/72 (94%), and social continence was preserved in 110/111 (99%) and 71/72 (99%) men. There was no rectal injury or Grade=4 adverse event. Grade 3 adverse events occurred in 9 men (8%), including GU infection, retention, pain, urinoma, and stricture; all were resolved before 1 year. Conclusions: Effective disease control is durable to 4 years, with continued recovery of quality of life and a favorable safety profile after whole-gland ablation with TULSA. SOURCE OF Funding: Profound Medical
